InstantGMP™, a provider of cloud-based GMP and FDA compliance software for pharmaceutical and other regulated manufacturers, announced it has aligned its software development and validation practices ...
Risk is a lens, not a leash. Once teams see what truly threatens patients and processes, the busywork falls away, and quality ...
After years of dialogue between the U.S. FDA and industry, the agency’s long-awaited draft guidance for computer software assurance (CSA) for manufacturing facilities signaled a new, less cumbersome ...
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